Prosthetic Valve Sealing Body for Missed Leaflet Capture
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Solution Overview
Problem
Existing prosthetic heart valves experience paravalvular leakage (PVL) due to challenges in securing the valve relative to intralumenal tissue and missed captures of leaflets by anchors, which compromise the sealing mechanism.
Innovation Solution
The prosthetic valve incorporates a sealing body configured to adapt to missed captures of leaflets by anchors, allowing the anchors to pass through and ensuring secure anchoring to the patient's heart, with features like flexible skirts and deflection mechanisms to reduce fluid flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If anchors are used to secure the prosthetic valve to native valve tissue, then anchoring reliability is improved, but paravalvular leakage occurs when leaflet capture is missed
Solution Approach 1:
The sealing function is segmented from the anchoring function. The sealing body is divided into multiple seal segments that can independently adapt to different anchoring scenarios, allowing each segment to respond to local conditions when leaflet capture is missed
Solution Approach 2:
The sealing body incorporates dynamic elements including flexible skirts that can deflect and adapt their position. This dynamic behavior allows the sealing body to automatically adjust and maintain sealing contact with the native valve tissue even when anchor placement varies or leaflet capture is missed
2Stability of the object's composition
If the sealing body is made rigid to maintain sealing position, then sealing stability is improved, but adaptability to missed leaflet captures deteriorates
Solution Approach 1:
Different portions of the sealing body have different mechanical properties. The sealing body includes rigid portions for structural support and stable positioning, while incorporating flexible skirt portions that can deflect and adapt locally when leaflet capture is missed, achieving both stability and adaptability through spatial variation of material properties
Solution Approach 2:
The sealing body is constructed as a composite structure combining materials with different mechanical characteristics. This includes rigid structural components for stability and flexible material components (such as flexible skirts) that provide adaptability, creating a unified sealing body that exhibits both stable overall positioning and local adaptive capability
3Reliability
If the prosthetic valve is designed with complex sealing mechanisms to prevent PVL, then sealing effectiveness is improved, but device complexity increases
Solution Approach 1:
The sealing body is merged with the anchor assembly such that the sealing function is integrated into the anchoring structure. The sealing body can be positioned to receive anchors and includes flexible skirts that extend into the valve annulus, combining sealing and anchoring functions in a unified structure rather than separate components
Solution Approach 2:
The flexible skirts of the sealing body automatically deflect and adapt to seal against the native valve tissue without requiring active control or additional actuation mechanisms. The structure self-adjusts based on the mechanical interaction during deployment and anchor capture, providing sealing effectiveness through passive adaptive behavior
Data Source
AI summary
Apparatuses, systems, and methods for prosthetic valves. Embodiments of prosthetic valves may include sealing bodies configured for an anchor to at least partially pass through. The pass through may allow for the sealing body to seal to a portion of a patient's heart in the event of a miscapture of a leaflet by the anchor. Embodiments may include modular valve systems and prosthetic valves including anchors for coupling to chordae, trabeculae, or papillary structures of a patient's heart. Embodiments may include prosthetic valves including anchors for engaging calcification of a patient's native valve.